Coated VICRYL VCP589H (UDI 10705031078673)Recalls & reported problems
Ethicon, LLC · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031078673), received between Jan 9, 2026 and Jan 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, HOSPITAL SISTER REPORTED THAT A SUTURE NEEDLE'S TIP BROKE OFF DURING AN ORTHOPEDIC SURGERY. THEY USED X-RAY TO SEARCH THE PATIENT AND DID NOT FIND ANY RESIDUAL NEEDLE MATERIAL IN THE PATIENT. VCL+ UD 27IN 2-0 S/A FSL - VCP589H (LOT: 106GZG) (VCP589H): LOT/BATCH NUMBER: 106GZG LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. ## *** WAS THERE ANY REPORTED PATIENT OR USER HARM? ## UNKNOWN *** WAS THERE A SIGNIFICANT DELAY? ## YES *** HOW LONG WAS THE DELAY (MINUTES)? ## NOT SURE *** IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). ## ***. VCL+ UD 27IN 2-0 S/A FSL - VCP589H (LOT: 106GZG) IS THE ACTUAL DEVICE WITH THE ALLEGED PRODUCT QUALITY ISSUE BEING RETURNED FOR ANALYSIS? OR IS AN ALTERNATIVE DEVICE BEING RETURNED? PLEASE SPECIFY ITEM WILL BE COLLECTED BACK FROM HOSPITAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24024044 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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